Safety, Efficacy and Evidence Base for Use of the Subcutaneous Implantable Cardioverter Defibrillator

Q: What is the clinical evidence from this study?

Study design: Review. Population: Sudden cardiac death prevention and life-threatening ventricular arrhythmias (VT/VF) in patients with structural heart disease or primary cardiac electrical syndromes. Intervention: Subcutaneous implantable cardioverter defibrillator (S-ICD) vs. Transvenous implantable cardioverter defibrillator (TV-ICD).

Q: What does this research mean for the field?

The subcutaneous implantable cardioverter defibrillator provides high efficacy in detecting and terminating ventricular arrhythmias while eliminating intravascular lead-related complications. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

Carmen Adduci; Francesca Palano; Pietro Francia

doi:10.3390/jcm7030053

March 11, 2018Journal of Clinical MedicineOpen Access

Safety, Efficacy and Evidence Base for Use of the Subcutaneous Implantable Cardioverter Defibrillator

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Key result

S-ICD terminates spontaneous VT/VF with ~97% efficacy while avoiding intravascular lead complications.

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Why the study?

What is the safety, efficacy, and clinical role of the subcutaneous implantable cardioverter defibrillator (S-ICD) compared to conventional transvenous ICDs in patients at risk for sudden cardiac death?

Key Points

To review the safety, efficacy, and clinical evidence for the entirely subcutaneous implantable cardioverter defibrillator compared to conventional transvenous systems.
Review of clinical evidence, procedural techniques, and registry outcomes evaluating subcutaneous implantable cardioverter defibrillators in patients at risk for sudden cardiac death.
Synthesized findings from key datasets, including a pooled analysis of the IDE study and EFFORTLESS registry (N=882) and extended EFFORTLESS follow-up (N=985).
A pooled analysis of IDE and EFFORTLESS registries demonstrated a 2% device infection rate, with 1.7% requiring explant or revision over an average of 651 ± 345 days.
Extended follow-up of EFFORTLESS (mean follow-up 3.1 ± 1.5 years) observed a 2.9% infection rate and a 2.4% explant rate, with no infections resulting in systemic dissemination.
Conventional transvenous leads carry failure rates up to 40% at eight years post-implant, with lead extraction procedures carrying complication risks and mortality exceeding 2%.

Structured PICO

What is the safety, efficacy, and clinical role of the subcutaneous implantable cardioverter defibrillator (S-ICD) compared to conventional transvenous ICDs in patients at risk for sudden cardiac death?

P

Population

Patients at high risk of sudden cardiac death (such as those with structural heart disease, cardiomyopathies, or primary cardiac electrical syndromes) who are candidates for an ICD without pacing or CRT indications.

I

Intervention

Entirely subcutaneous implantable cardioverter defibrillator (S-ICD) implanted via three-incision, two-incision, or intermuscular technique, programmed to deliver 80 J shocks with dual-zone detection (conditional VT zone 170-220 bpm and VF zone >220 bpm) and up to 30 seconds of post-shock transthoracic pacing.

C

Comparator

Conventional transvenous implantable cardioverter defibrillator (TV-ICD).

Limitations

Longer-term follow-up is needed to ascertain the true incidence of S-ICD lead failure.
Whether an S-ICD is completely equivalent to a TV-ICD in patients without a pacing indication remains unaddressed pending randomized trial data (PRAETORIAN).
Longer-term follow-up is needed to ascertain the true incidence of S-ICD lead failure
The question of whether an S-ICD is completely equivalent to a TV-ICD in patients without a pacing indication is presently unaddressed by completed randomized trials

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Implication

This review summarizes registry and clinical trial evidence demonstrating that the subcutaneous ICD is a safe and effective alternative to transvenous ICDs for preventing sudden cardiac death in patients without pacing indications, avoiding intravascular lead failures and systemic infections.

Abstract

The trans-venous implantable cardioverter defibrillator (TV-ICD) is effective in treating life-threatening ventricular arrhythmia and reduces mortality in high-risk patients. However, there are significant short- and long-term complications that are associated with intravascular leads. These shortcomings are mostly relevant in young patients with long life expectancy and low risk of death from non-arrhythmic causes. Drawbacks of trans-venous leads recently led to the development of the entirely subcutaneous implantable cardioverter defibrillator (S-ICD). The S-ICD does not require vascular access or permanent intravascular defibrillation leads. Therefore, it is expected to overcome many complications associated with conventional ICDs. This review highlights data on safety and efficacy of the S-ICD and is envisioned to help in identifying the role of this device in clinical practice.

Discussion

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Cite This Study

Adduci et al. (2018) conducted a review in Sudden cardiac death prevention and life-threatening ventricular arrhythmias (VT/VF) in patients with structural heart disease or primary cardiac electrical syndromes. Subcutaneous implantable cardioverter defibrillator (S-ICD) vs. Transvenous implantable cardioverter defibrillator (TV-ICD) was evaluated. The subcutaneous ICD demonstrates high efficacy in converting spontaneous VT/VF while avoiding intravascular lead complications.

synapsesocial.com/papers/6a7af1f62eb3c7e469f43071 https://doi.org/10.3390/jcm7030053

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Safety, Efficacy and Evidence Base for Use of the Subcutaneous Implantable Cardioverter Defibrillator

Figures

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Safety, Efficacy and Evidence Base for Use of the Subcutaneous Implantable Cardioverter Defibrillator

Figures

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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